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Food and Drug Administration Reformulation of OxyContin

Abimbola Farinde, Pharm.D., is a clinical pharmacist specialist with specializations in psychopharmacology and geriatrics.

The recent Food and Drug Administration (FDA) approval of an abuse deterrent label for the reformulated OxyContin can be viewed by many members of the medical and healthcare community as an indication of the FDA’s growing awareness of the public health crisis and the apparent growth of OxyContin “abuse” to an epidemic “status.” It has been reported that less than 10 percent of the United States population abuses opiates in their lifetime with the street opiate, OxyContin being among the drugs of choice. The new labeling specifically indicates that the associated physical and chemical properties of the new formulation will make it difficult for abuse via intranasal administration. OxyContin manipulation, e.g., crushing, breaking, or dissolving, causes more rapid delivery of the drug to achieve a euphoric effect, but manipulation can also increase the abuser’s susceptibility to overdose or death. The priority that has been placed on the development of the abuse deterrent reformulation of OxyContin may have the potential to save many lives that can be lost senselessly each year to the abuse of this drug among many others.

The potential for manipulation and the opportunity to abuse OxyContin has been substantially reduced with the reformulation, which can be viewed as a significant breakthrough in an effort to curtail inappropriate use and promotion that falls within the confines of the safety and efficacy of the drug. The requirement for closer monitoring and development of abuse deterrent mechanisms for other drugs has the potential to substantially reduce abuse behavior and patterns of abuse in our society.

Given the rampant abuse associated with OxyContin, would it be prudent for the FDA to consider other drug classes that are also being largely abused?

To some extent this may occur, but the benefits of reformulated drugs clearly appear to outweigh the current risks. The sole purpose of these reformulated agents are to deter the potential for abuse while not diminshing the positive therapeutic effects of that particular agent.

It appears that this reformulation is more of an opportunity to deter abuse and prevent the pleasurable/euphoric effect that can be achieved through it various manipulations. It is hoped that once the opportunity is removed through the abuse deterrent mechanism it may diminish the drug seeking behavior that has become rampant with this drug over the years.

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